Heard about this on the 11PM news tonight:

Medtronic link:

http://www.medtronic.com/kappasigma/patient.html
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CNNMoney.com story:

Medtronic Inc. (MDT) on Monday sent doctors around the world a letter telling them about potential issues with wires in some older pacemakers that affects about 37,000 devices and may lead doctors to remove and replace some of them.

The issues covered in the "Dear Doctor" letter involves a small fraction of the more than 1.7 million "Kappa" and "Sigma" pacemakers implanted in the last 12 years. The letter included a new problem with both pacemakers and an issue with Sigma devices that was first identified in 2005 but has caused a higher- than-expected failure rate.

Medtronic currently considers the risk of device failure to be less than 4% over the lifespan of most affected pacemakers. And in cases where one does fail, the vast majority of patients have slow heart rhythms that would cause lightheadedness or fainting, but not life-threatening complications, Medtronic said.

Doctors should advise patients with these symptoms to seek medical attention right away, Medtronic said. Doctors should also continue to routinely follow-up in accordance with standard practices for patients who don't require full-time pacemaker therapy.

There is a risk of serious consequences, on the other hand, for the small number of patients who do need pacemakers to provide life-saving therapy at all times. "Physicians should consider device replacement" in such cases, Medtronic said in the letter.

Medtronic noted that there have been two reports of patient deaths where it is possible, but unclear, that the wiring issue may have played a role.

The company posted the letter to doctors and one to patients on its Web site along with a tool for checking pacemaker serial numbers to determine whether their devices could potentially have issues. The company advised patients with problem devices to seek medical attention right away if they faint or feel lightheaded.

The problems covered by the letter seem fairly modest in scope based on what Medtronic has found so far. Pacemakers are routinely removed from patients' chests and replaced due to aging batteries, and some affected devices may be near the end of their life spans.

There are different reasons why the Kappa and Sigma pacemaker wires may fail, including a wire-separation problem more recently found and an issue with a cleaning solvent used during manufacturing that was found a few years ago and affects 15,600 Sigma devices.

Medtronic originally predicted a very small 0.17% to 0.3% failure rate for that Sigma group, but has since seen a higher rate and now predicts a 3.9% failure rate over the device's lifespan. On average, these Sigma pacemakers are expected to last another 3.3 years.

Medtronic had initially considered this an issue that required watchful waiting, but now believes doctors should consider replacing devices for some patients due to the higher failure rate.

The newer-wires issue involves 15,200 Kappa devices and 6,100 Sigma devices. For that Kappa group, Medtronic has seen a 0.49% failure rate and predicts a 1.1% rate over the devices' lifetime. For the second group, Medtronic has seen a 0.88% failure rate and predicts the rate will reach 4.8% over the devices' lifetime.

The company also noted that there are also about 96,000 Kappa devices with a tiny failure rate that isn't expected to increase much, and it doesn't recommend any action regarding those devices.

Shares of Medtronic, which will report quarterly results on Tuesday, rose 1.7% to close at $33.96 on Monday.

http://money.cnn.com/news/newsfeeds/articles/djf500/200905181849DOWJONESDJONLINE000539_FORTUNE5.htm

 

 

My 2nd pm was implanted in 2005 mainly because my first one was implanted in 1987 so had a good run really.
I must admit, even my partner agrees with me that I have not been so well since having this one and it is a Medronic Pacer.
Should I telephone my hospital and enquire or just leave it until my next pacer check. I should imagine hospitals are getting quite a lot of these calls.
Anyone else having problems with their pacer
Regards
Fluzy Suzy

 

You can go to the Medtronic web site and enter your pacemaker's serial number to see if it's one of the ones they are having issues with or just contact your doctor.

 

hello, i received a letter from medtronic concerning my pacer. it is in a class which is associated with the circuitry problem. since it is 8 yrs. old it will be replaced in the early fall of 2009.
my 'electric man' has also recommended an echo stress test fairly shortly because he found something 'haywire" with the ventricals. of course i'm aged 62 and things do get a little crazy as we age.
if their are others with the kappa sigma, let's talk.
thanks,
phunny